MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..
[123967423]
We have received the device for evaluation and we were able to confirm the reported incident. The resector did not rotate at all when the window lock button was pressed. The resector rotated intermittently when the run button was pressed. We noted the handpiece cable and the outside of the endbell connector to be wet and observed debris around the bezel area. The wet connector cable and outer end bell face indicates that the cord was removed during cleaning and sterilization. The motor was noted to be corroded. The o-rings on the distal end of the seal housing was observed to be damaged. It is possible that the water entered inside the handpiece due to this failure corroding the motor. The probable root cause of the defect is a damage to the motor and the pc board due to water exposure during sterilization. Our ifu states not to remove the cable from the handpiece and secure the cable end with the protective cap during sterilization. We also currently have a corrective and preventive action (capa) open to address this issue. There was no injury to the patient as the result of this incident.
Patient Sequence No: 1, Text Type: N, H10
[123967424]
During pre-use check, the handpiece failed to work properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00083 |
| MDR Report Key | 7970585 |
| Date Received | 2018-10-16 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-09-16 |
| Date Mfgr Received | 2018-09-17 |
| Date Added to Maude | 2018-10-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRIVEX SYSTEM RESECTOR HANDPIECE |
| Generic Name | VARICOSE VEIN ALBATION SYSTEM |
| Product Code | DWQ |
| Date Received | 2018-10-16 |
| Returned To Mfg | 2018-09-26 |
| Catalog Number | 7210387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 02148 US 02148 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-16 |